Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY X4 - RALLY X4

Boston Scientific Cooperation International0 个研究点目标入组 350 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•- Subject is willind and capable of providing informed consent
•- Subject is planned to be implanted with an ACUITY X$ lead for left-ventricular pacing and sensing via the coronary venous system in conjunction with a compatible BSC pulse generator
•- Subject is willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined by this CIP
•- Subject os age 18 or above, or of legal age to give informed consent specific to state and national law

•- Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate
•- Subject is enrolled in any other concurrent study without prior written approval from BSC, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
•* schedule of procedures for the Rally X4 Study (i.e. should not cause additional or missed visits);
•* Rally X4 Study outcome (i.e. involve medications that could affect the heart rate of the subject);
•* Conduct of the Rally X4 study per GCP/ISO 14155:2011 / local regulations as applicable
•- Per the implanting physician's discretion, the subject is not a sauitable candidate to receive the study device as determined during the implant procedure
•- Women of childbearing potential who are or might be pregnant at the time of study enrollment
•- Subject is unwillingor unable to participate in all scheduled study follow up visits at an approved study center
•- Subject does not anticipate being a resident of the area for the scheduled duration of the trial
•- Subject's physician does not allow participation

发起方

Boston Scientific Cooperation International